Actos

Actos

pioglitazone

Manufacturer:

Celltrion Healthcare

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Pioglitazone HCl
Indications/Uses
Monotherapy & combination therapy w/ sulfonylurea, metformin or insulin, adjunct to diet & exercise to improve glycemic control in patients w/ type 2 DM.
Dosage/Direction for Use
Monotherapy Initially 15 or 30 mg once daily. Max: 45 mg once daily. Combination therapy Initially 15 or 30 mg once daily w/ current sulphonylurea, metformin or insulin dose. Max: 45 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. NYHA class III or IV heart failure.
Special Precautions
Do not use in patients w/ type 1 diabetes for the treatment of diabetic ketoacidosis. History of bladder cancer. Do not initiate in patients w/ active bladder cancer. Reduce dose in concomitant use w/ antidiabetic therapy (insulin or oral hypoglycemic agents). CHF, symptomatic heart failure, edema, macular edema. Closely monitor patient wt. Ovulation may occur in premenopausal anovulatory women; adequate contraception is recommended. Monitor liver enzymes prior to initiation & periodically thereafter. Patients w/ mildly elevated liver enzymes. Evaluate serum ALT levels prior to initiation of therapy & periodically thereafter. Discontinue therapy if jaundice is observed. Regular eye exam for diabetic patients. Increased incidence of bone fracture especially in women. Perform fasting plasma glucose & HbA1c measurements periodically. Caution in patients who experience visual disturbance when driving or using machines. Renal insufficiency. Pregnancy & lactation. Not recommended in childn <18 yr.
Adverse Reactions
Edema, body wt increase, decreases in Hb & hematocrit, increase in creatine kinase (creatine phosphokinase, cardiac failure, hepatocellular dysfunction, macular edema, bone fracture in women. URTI, headache, sinusitis, myalgia, tooth disorder, aggravated DM, pharyngitis. Mild to moderate hypoglycemia during combination therapy.
Drug Interactions
Increased AUC w/ CYP2C8 inhibitor (eg, gemfibrozil). Decreased AUC w/ CYP2C8 inducer (eg, rifampicin). Risk of hypoglycemia w/ insulin or other antidiabetic medications.
MIMS Class
Antidiabetic Agents
ATC Classification
A10BG03 - pioglitazone ; Belongs to the class of thiazolidinediones. Used in the treatment of diabetes.
Presentation/Packing
Form
Actos tab 15 mg
Packing/Price
30's
Form
Actos tab 30 mg
Packing/Price
30's
Form
Actos tab 45 mg
Packing/Price
28's
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